Clinical Research Directory
Browse clinical research sites, groups, and studies.
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Sponsor: Sunway University
Summary
This multicentre, prospective, single-arm cohort study will evaluate the real-world effectiveness and safety of Savagen, an NPRA-approved generic sacubitril/valsartan, in Malaysian adults aged 18 to 70 years with heart failure with reduced ejection fraction (HFrEF; LVEF ≤40%, NYHA class II-III). Approximately 80 patients initiating Savagen as part of routine clinical care at hospitals offering a Heart Failure Medication Therapy Adherence Clinic (HFMTAC) will be followed for 12 months. The primary outcome is the change in NT-proBNP from baseline to 12 months. Secondary outcomes include changes in LVEF, renal function (serum creatinine, eGFR), serum potassium, patient-reported health status (KCCQ) and dietary diversity (Dietary Diversity Score), a composite of cardiovascular death or first heart failure hospitalisation, and adverse events, including hypotension, hyperkalaemia, renal impairment and angioedema. The study does not aim to establish equivalence with the reference product; it will generate local real-world evidence on the effectiveness, tolerability, safety and patient-reported outcomes of generic sacubitril/valsartan in routine Malaysian HFrEF care.
Official title: Real-world Effectiveness and Safety of Savagen in Malaysian Patients With HFrEF: A Prospective Cohort Study
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2026-10-01
Completion Date
2028-09-30
Last Updated
2026-10-30
Healthy Volunteers
No
Interventions
Savagen (sacubitril/valsartan)
Generic sacubitril/valsartan initiated and titrated by the treating physician according to standard institutional protocol and clinical guidelines. The study protocol does not prescribe a dose.
Locations (2)
Hospital Sultan Idris Shah Serdang
Kajang, Selangor, Malaysia
Hospital Shah Alam
Shah Alam, Selangor, Malaysia